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Weekly Drug News Round Up - December 19, 2012

Fluarix Quadrivalent Vaccine Approved for Seasonal Flu

Latest vaccine covers four influenza strains instead of the typical three Read More...

The currently available trivalent (three-strain) influenza vaccines protect against two common A viral strains and the B strain predicted to be most common for that flu season. However, additional B viral strains have been circulating since the year 2000, putting the public at risk of increased exposure to influenza illness. In response, the U.S. Food and Drug Administration (FDA) has approved Fluarix Quadrivalent (Influenza Virus Vaccine), the first intramuscular vaccine to cover against four influenza strains. Fluarix Quadrivalent helps protect against the two A strains and adds coverage against a second B strain. The vaccine is approved for use in children three years and older and adults.

New Boxed Warning Added to Incivek Drug Label

Incivek combination treatment to be stopped in patients with a progressive severe rash or a rash with systemic symptoms Read More...

FDA has received reports of serious and sometimes fatal skin reactions occurring in patients combining the use of the hepatitis C drug Incivek (telaprevir) with peginterferon alfa and ribavirin (Incivek combination treatment). Fatalities occurred in patients who continued to receive Incivek combination treatment after developing a worsening or progressive rash and symptoms affecting the entire body. If serious skin reactions occur, all three components of Incivek combination treatment must be immediately stopped, and the patient should receive urgent medical care. Consideration should also be given to stopping any other medications that may be associated with serious skin reactions.

Orphan Drug Signifor Approved for Cushing’s Disease

Signifor may cause or worsen diabetes, and blood sugar levels will need to be carefully monitored Read More...

Cushing’s disease is caused by excess production of cortisol, and may result in weight gain, diabetes, high blood pressure, easy bruising, and increased risk for infections. Signifor (pasireotide diaspartate) injection has been FDA-approved for the treatment of Cushing’s disease in patients who cannot have or are not helped by surgery. In a clinical trial of 162 patients, Signifor reduced cortisol levels as early as one month after initiation. Roughly 20 percent of patients were able to reduce urine cortisol levels into the normal range. The most common adverse reactions observed in the clinical trial included hyperglycemia, diarrhea, nausea, abdominal pain, and gallstones.

Raxibacumab Injection Approved to Treat Inhalational Anthrax

Common side effects of raxibacumab included rash, extremity pain, itching and drowsiness Read More...

The U.S. Food and Drug Administration (FDA) has approved raxibacumab injection to treat or prevent inhalational anthrax which is caused by breathing in the spores of Bacillus anthracis that produce lethal toxins in the blood. Antibiotics such as ciprofloxacin can kill the anthrax bacteria, but they are not effective against the deadly toxins. Raxibacumab is the first monoclonal antibody approved under the FDA’s Animal Efficacy Rule, which allows findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in humans.

FDA Accelerates Approval for Leukemia Drug Iclusig

Iclusig (ponatinib) is a kinase inhibitor that blocks certain proteins that promote the development of cancerous cells Read More...

The U.S. Food and Drug Administration (FDA) has approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases. FDA approved Iclusig more than three months early under a priority drug review. Iclusig is the third drug approved to treat CML and the second drug approved for ALL this year - Bosulif (bosutinib) and Synribo (omacetaxine mepesuccinate) were approved to treat CML in the fall of 2012, and in August 2012 Marqibo (vincristine sulfate liposome injection) was approved for ALL.